Laboratory Test Request Details

Medical Devices and In-Vitro Diagnostics Test Request


Request: 16-01021

Status: Closed


Description:

FDA Electrical medical device laboratory needed for Skin massager testing:
2. FDA Product Code : PBX
3. Performance test standard
? IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
? IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility ? Requirements And Tests.
? IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.
? IEC 60601-2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.


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